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FDA Reviews RSV Drugs Amid Vaccine Guidance Controversy

12/10/2025

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Story summary
  • The U.S. Food and Drug Administration has opened a safety review of two injectable RSV drugs from Merck and Sanofi.
  • The review coincides with Health Secretary Robert F. Kennedy Jr.'s rollback of routine childhood vaccinations.
  • Merck and Sanofi report no new safety concerns about their RSV products.
  • Kennedy's leadership has driven vaccine guidance changes, including a panel's call to end routine hepatitis B vaccinations for newborns, triggering backlash.